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Study of LY3537982, pembrolizumab, and a drug combination for patients with advanced non-small cell lung cancer and a KRAS G12C mutation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates treatments for non-small cell lung cancer, a type of lung cancer, specifically in cases that are locally advanced or metastatic, meaning the cancer has spread to other parts of the body. The research focuses on patients whose cancer contains a specific genetic change known as a KRAS G12C mutation. The purpose of the study is to compare the effectiveness of different drug combinations used as a first-line treatment.

Participants may receive a combination of LY3537982 and pembrolizumab. In some groups, additional medications such as pemetrexed and a platinum-based chemotherapy, which includes cisplatin or carboplatin, may be used. Other participants will receive pembrolizumab along with pemetrexed and platinum combined with a placebo. The study also looks at the role of PD-L1 expression, which is a protein found on certain cells that can affect how the immune system recognizes cancer.

The study process involves determining the most effective dose of LY3537982 when used alongside other medicines. Depending on the assigned group, patients will receive medications through oral capsules or as a solution for injection. The course of the study involves monitoring how the different combinations of these drugs work together to manage the disease.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment administration

    The treatment consists of different combinations of medications based on the assigned group.

    One group receives pembrolizumab, which is an injection at a dose of 200 mg, along with either the test drug LY3537982 taken as an oral capsule or a placebo, which is an inactive substance used for comparison.

    Another group receives pembrolizumab (200 mg injection), pemetrexed (an injection at 500 mg/m2, where m2 refers to the body surface area), and a platinum-based medication (either cisplatin at 75 mg/m2 injection or carboplatin at 25 mg injection), combined with either the test drug LY3537982 (oral capsule) or a placebo.

  2. Step 2

    Monitoring progress

    The effectiveness of the treatment is evaluated by measuring the progression-free survival, which is the length of time during and after treatment that the disease does not get worse.

Who can join the trial?

5 criteria

  • You must have non-small cell lung cancer, which is a common type of lung cancer that does not start in the inner lining of the airways, and this cancer must be advanced, meaning it has grown significantly or spread to other parts of the body.
  • Your cancer must have a specific genetic change known as a KRAS G12C mutation, which is a change in the instructions within your cells that can cause them to grow uncontrollably.
  • You must have a PD-L1 expression level between 0% and 100%; PD-L1 is a protein found on some cancer cells that can help the cancer hide from the immune system, and measuring it helps doctors predict how well certain treatments might work.
  • You must be able to swallow capsules (medicine in a small shell) or tablets (solid pieces of medicine).
  • You must be physically well enough to walk and perform light work, which refers to activities that do not require heavy lifting or intense physical exertion.

Who cannot join the trial?

5 criteria

  • You may not participate if you have other types of genetic mutations, which are changes in your DNA, such as EGFR, ALK, BRAF, HER2, MET, ROS1, RET, or NTRK, because these require different types of targeted treatments.
  • You cannot join if you have cancer that can be fully cured using localized treatments, such as surgery (removing the tumor) or radiation (using high-energy beams to kill cancer cells).
  • You are excluded if you have an active infection, which is a current illness caused by germs like bacteria or viruses, or any other serious medical conditions aside from your cancer.
  • You cannot participate if you have active heart disease that causes symptoms, or if you have a history of heart attack or chest pain within the last 6 months.
  • You are not eligible if you have a known allergic reaction to any of the medicines used in this study, which include LY3537982, pembrolizumab, pemetrexed, or platinum-based drugs.
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Investigated drugs

  • LY3537982

    is an experimental medication taken orally in capsule form that is being tested to see how well it works when combined with other treatments for certain types of lung cancer.

  • Pembrolizumab

    is an immunotherapy medication given as an injection that helps the body's own immune system recognize and attack cancer cells.

  • Pemetrexed

    is a chemotherapy medication given as an injection that works by stopping cancer cells from growing and dividing.

  • Cisplatin

    is a chemotherapy medication given as an injection that is used to treat cancer by interfering with the ability of cancer cells to repair their DNA.

  • Carboplatin

    is a chemotherapy medication given as an injection that is used to treat various types of cancer by damaging the DNA of cancer cells to prevent them from multiplying.

What is already known about the treatment

  • Cisplatin

    This medication is a chemotherapy drug administered as a solution through an injection into a vein. It is a well-established treatment used to fight various types of cancer by entering cancer cells and attaching to their DNA, which prevents the cells from multiplying and eventually causes them to die. It is classified as a platinum-based antineoplastic agent.

  • LY3537982

    This experimental medication is taken orally in the form of a capsule. It is currently being studied in clinical trials to see if it can effectively treat specific types of lung cancer. The drug works at a molecular level by targeting specific mutations in cancer cells to stop their growth, and it is classified as a targeted therapy.

  • Pembrolizumab

    This medicine is an immunotherapy drug given as an injection into a vein. It is widely used in medical practice to treat several types of cancer by blocking a specific protein on immune cells that prevents them from attacking the tumor. This allows the body's own immune system to recognize and destroy cancer cells more effectively.

  • Pemetrexed

    This chemotherapy medication is administered as a solution through an injection into a vein. It is commonly used to treat certain lung cancers by interfering with the cells' ability to use folate, a necessary nutrient for building DNA. By disrupting this process, the drug prevents cancer cells from growing and dividing.

  • Carboplatin

    This is a chemotherapy drug that is given to patients as a solution through a vein injection. It is a standard treatment for many types of cancer and works by binding to the DNA of cancer cells to damage their genetic material. This damage stops the cancer cells from reproducing, leading to their death.

Investigated diseases

Non-small cell lung cancer with KRAS G12C mutation - This is a type of lung cancer that begins in the cells that make up the airways and lung tissue. It is characterized by a specific genetic change in the KRAS gene known as the G12C mutation. The disease occurs when cells in the lung grow and divide uncontrollably. As it progresses, the cancer can spread from its original location to other parts of the lungs or different organs in the body. In more advanced stages, the tumor becomes more extensive and can involve nearby structures.
Trial detailsLast updated 15 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503412-33-00Protocol codeJ3M-MC-JZQBEstimated enrolment1 186 patientsSponsorEli Lilly & Co.

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